Vaccine for Infant Diarrhea Is Withdrawn as Health Risk

By LAWRENCE K. ALTMAN

Published: October 16, 1999

ATLANTA, Oct. 15—
American Home Products, the manufacturer of the only licensed vaccine to prevent the most common cause of severe diarrhea among infants and children, announced today that it was withdrawing the vaccine from the market because of concerns that it could cause a painful and potentially fatal bowel obstruction.

The diarrhea is caused by the rotavirus, and last year the Government recommended that every infant in the United States get the protective vaccine. One million children swallowed three doses of the vaccine, Rotashield, at 2, 4 and 6 months of age, the company said.

But in July the Centers for Disease Control and Prevention, a Federal agency based here, said no one should get the vaccine because a program that monitors side effects suggested a link between the vaccine and the bowel condition, called intussusception.

Today, prompted by more than 100 reports of intussusception to the agency -- more than half of them within a week of vaccination -- American Home Products asked doctors and health workers to return all unused vaccine immediately. It said it would wait for completed studies to determine whether withdrawal of the vaccine would be permanent.

The drug company's action leaves the United States without a rotavirus vaccine just at the time when the virus tends to occur most often, from November to May. Rotavirus infects more than half a million American children, usually from 3 to 35 months of age, and leads to 500,000 doctors' visits, 50,000 hospitalizations and about 40 deaths, officials at the disease centers said.

Rotavirus is also said to be be the biggest diarrheal killer of children around the world, accounting for 600,000 deaths a year, chiefly from dehydration.

Rotashield has been approved for use in Europe but has not been marketed there, said Doug Petkus, a spokesman for American Home Products. Researchers are working on half a dozen other rotavirus vaccines, but they are still in experimental stages.

The developments are highly embarrassing to Federal health officials. The vaccine was developed at the National Institutes of Health. Even before the Food and Drug Administration licensed the vaccine to Wyeth-Ayerst Laboratories, a subsidiary of American Home Products, the disease centers promoted it as the new weapon against rotavirus.

Rotashield is also the latest in a series of problems for American Home Products, of Madison, N. J. Last week, the company agreed to pay at least $3.75 billion to settle claims that its half of the diet drug combination fen-phen caused heart problems. And over the last year, it withdrew the painkiller Duract because it caused fatal liver problems; agreed to a multimillion-dollar settlement of lawsuits claiming that the contraceptive Norplant caused side effects, and recalled more than half a million kits used to treat deadly allergic reactions because they were apparently not potent enough.

The company's action comes one week before a C.D.C. advisory committee on vaccines is scheduled to meet here to review studies to determine whether the vaccine led to bowel obstruction. Full data will not be complete by the time of the meeting on Oct. 22, officials of the centers and the drug company said.

As of Sept. 24, the disease centers had received reports of intussusception among 108 infants. Of these, 63 were confirmed cases and 36 others were strongly suspected. Five are confirmed as not having intussusception, and one infant did not receive the vaccine. Data were insufficient to classify three cases.

An important concern is that of the 96 confirmed or suspected cases, 56 had onset of symptoms within a week of receiving the vaccine and 9 others had onset within the second week.

The disease centers' director, Dr. Jeffrey P. Koplan, said the findings would still be discussed at the meeting because the scientific review was continuing and would not be affected by the product's withdrawal.

''As planned, C.D.C. will seek a recommendation from the Advisory Committee on Immunization Practices regarding the use of this vaccine among children in the U.S.,'' Dr. Koplan said.

Both he and American Home Products said there was no risk to children who have already been vaccinated and had no bowel problems.

Intussusception results when a section of bowel slides inward, like a telescope, into another part of the bowel. In severe cases, a previously healthy infant suddenly screams in paroxysms of pain. Other symptoms include persistent vomiting and a bowel movement that appears black.